EUCTR2008-003327-23-DE进行中（未招募）不适用
Phase III, Open-Label, Multicenter International Study to Evaluate the Efficacy and Safety of an Octreotide Implant and/or Sandostatin LAR® depot in Patients with Acromegaly
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 140
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients meeting all of the following criteria will be considered for admission to the study
- •1. Male or female with acromegaly
- •2. Age >=18 years and = 80 years
- •3. Confirmed diagnosis of a growth hormone-secreting tumor based on historical data and meeting at least one of the following criteria (a or b):
- •a. Patients in whom an OGTT was performed and meeting all of the following (based on previous historical data):
- •i. GH = 1.0 ng/mL during the OGTT and
- •ii. IGF-1 level = 20% above the upper limit of age-and sex-adjusted normal value during the OGTT and
- •iii. Pituitary tumor demonstrable on MRI
- •b. Patients in whom an OGTT was not performed and meeting all of the following (based on previous historical data):
- •i. IGF-1 level = 20% above the upper limit of age-and sex-adjusted normal value and
- •ii. Confirmation of a growth hormone-secreting tumor on pathologic examination of tissue removed at surgery and
- •iii. Pituitary tumor demonstrable on MRI
- •4. No pituitary tumor present or has tumor present that is = 3 mm in distance from the optic chiasm
- •5. Received a stable dose of monthly octreotide depot injections for a minimum of 3 consecutive months immediately prior to Screening
- •6. Must show a response to octreotide treatment with documented laboratory results at the Screening visits (mean of Day -60 and Day -30 results) defined as follows:
- •a. IGF-1 < 20% above the normal age and sex-adjusted levels and GH = 2.5 ng/mL
- •7. Without, in the opinion of the investigator; clinically significant findings on physical exam, laboratory values, and vital signs; or unstable chronic medical conditions
- •8. Be able to communicate, complete questionnaires independently, provide and sign written informed consent, and willing to participate and comply with study requirements
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients presenting with any of the following will not be considered for admission to the study.
- •1. Women who are pregnant, lactating, or of child-bearing potential who are not
- •practicing a medically acceptable method of birth control listed below:
- •For females of childbearing potential, negative serum pregnancy test prior to enrollment, not breastfeeding for study duration, and willingness to use accepted forms of reliable birth control for study duration [including bilateral tubal ligation, use of oral contraceptives, double barrier methods (diaphragm with spermicidal gel or condoms with contraceptive foam), Depo-Provera®, hormonal implants, partner vasectomy, and total abstinence]. Pregnancy tests are not required (indicate n/a”) for males, or for females not of childbearing potential (post-menopausal with last menstrual period >1 year ago or total hysterectomy with bilateral oophorectomy)
- •2. Pituitary surgery less than 3 months prior to Screening
- •3. Liver disease (e.g., cirrhosis, chronic active or persistent hepatitis or persistent abnormalities of ALT, AST (level > 2X normal), alkaline phosphatase (level > 2X normal), or direct bilirubin (level > 1.5X normal))
- •4. Other laboratory values considered by the Investigator or Sponsor to be clinically significant.
- •5. Unstable angina, sustained ventricular arrhythmias or heart failure (NYHA III and IV)
- •6. Acute myocardial infarction within 3 months of Screening
- •7. Uncontrolled diabetes defined as having a fasting glucose > 150 mg/dl and HbA1c = 9 %
- •8. Symptomatic cholelithiasis
- •9. History of drug or alcohol abuse within 6 months of Screening
- •10. Received any investigational drug or participated in another clinical trial within 30 days of Screening
- •11. Received radiotherapy for pituitary tumor or any radiotherapy above the neck at any time before the start of Screening
- •12. Received pegvisomant lanreotide or a dopamine agonist within 3 months of Screening, or at any time during the trial
- •13. Received a previous octreotide implant
- •14. History or presence of significant cardiovascular, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, psychiatric disease, any other severe coexisting or terminal systemic disease that limits life expectancy or may interfere with the conduct of the study, or patients who are incarcerated in penal institutions or are committed to mental institutions
- •15. Candidate on a waiting list for surgery while on study
- •16. Patient who, through completion of the study, would have donated in excess of:
- •a.500 mL of blood in 42 days;
- •b.1500 mL of blood in 180 days; or
- •c.2500 mL of blood in 1 year
- •17. Received new or non-stable dose of hormone replacement therapy within 3 months of Screening. Any waiver of these inclusion and exclusion criteria must be approved by the Investigator and the Sponsor on a case-by-case basis prior to enrolling the patient. The waiver must be documented by the Investigator and the Sponsor. No patient will be allowed to enroll in this study more than once.
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